Patient Safety Director

The position of Patient Safety Director is open in a large foreign company

Main responsibilities:

Patient Safety Management and Regulatory Compliance

• Manage local PS team and/or PS activities at the local country level to ensure compliance with local health authorities regulations & Companies Requirements.
• Responsible for  Companies compliance with prevailing local regulatory requirements governing the conduct of pharmacovigilance.
• Ensure elements of Good Pharmacovigilance Practice are implemented at the local level.
• Ensure the appointment of appropriately qualified personnel to act as the Local Qualified Person  for Pharmacovigilance (LQPPV) and deputy LQPPV.
• Complete all required patient safety training and adhere to  internal processes and external regulations.
• Ensurefull and prompt response to any patient safety query from the local regulatory authority related to patient safety function.
• Ensure local processes, procedures, and systems are in place for  collection, processing (including follow-up and archiving), and reporting of clinical and post-marketed adverse events from all sources to meet  Companies pharmacovigilance standards and local regulatory requirements.
• Support audit & inspection process & respond to all related  queries and manage the identified gaps as per GVP.
• Management of safety agreements & local Business Continuity  plan.
• Manage adverse event reporting training to local Companies  employees and external service providers according to global patient safety standards.
• Review job descriptions, training records, and curriculum vitae for the local Patient Safety team at least annually to ensure compliance with  quality management requirements.
• Ensuring local PS procedures are established at the local level and in compliance with Companies and global/local regulatory requirements.
• Maintain oversight of the external vendor engagement and core deliverables, to ensure delivery per requirements and external  regulatory standards.
• Support management of local safety agreements and update  Pharmacovigilance Agreement Listings.
• Manage the Reconciliation process related to ODCP, MI, PQC, and MSL  insights to ensure the accuracy of pharmacovigilance data that is  transferred & received.
• Update and submit the annual patient safety checklist.
• Ensure an after-hours process is in place, to ensure a customer can report an AE and respond to regulatory authority questions.
• Supports filing and archiving practices of patient safety  documents.
• Ensure monitoring of different digital activities (websites, applications, social media pages, etc) as per Companies global procedure.
• Ensure Quality Issues are captured on Companies systems and CAPAs are closed on time.
• Monitor PS compliance reports and provide guidance and support to the local PS team.

Pharmacovigilance and Risk Management

• Support the creation, implementation, and maintenance of local risk management plans and risk minimization activities to support regulatory  submissions in collaboration with cross-functional teams.

Conduct activities, interactions, and cross-functional Collaboration

• Work with the Patient Safety team to establish strong relationships   and effective collaboration between Regulatory, Marketing, Medical  Affairs, Clinical, and other internal and external stakeholder functions      to deliver patient safety requirements for business and regulatory needs.
• Lead PS projects at local and global levels.
• Conduct activities and interactions consistent with Companies  values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to the role.

Team Management and Development

• Accountable for People management and development
• Support the Development of the capabilities of the local PS  functional team.
• Develop individual and team accountability.
• Encourage identification of opportunities for operational  improvement and coordinate implementation of improvement initiatives,  including, but not limited to, policies, procedures, standards, guidance,      training programs, and system improvements.
• Establish and maintain a high-performance culture through the application of performance management processes.
• Identify team training needs and commit resources to ensure  development initiatives are delivered.
• Ensure team development by updating Individual development plans for each team member and providing support to accomplish the plans.

Budget planning and Resource allocation

• Develop, monitor and an annual budget and ensure resource  optimization.
• Management & Development of PS Resources.

Pharmacovigilance network and Health Authorities Partnership

• Work on the development of a strategic partnership with local   health authorities, aligning Companies patient safety objectives with the  overall objectives of the health authority and the needs of the local   community.
• Work with local pharmacovigilance industry networks to establish effective collaboration to ensure  Companies voice is heard in discussions about the regulatory needs of our product portfolio in terms of patient safety.

Working environment:

• Work in an international innovative company
• The level of compensation is discussed individually
• Annual bonus
• Corporate car
• Medical insurance
• Corporate mobile communication
• 3 days day-off